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EC number: 308-114-5 | CAS number: 97862-65-2
Toxicological information
Acute Toxicity: oral
Currently viewing:
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982-09-20 to 1982-10-06
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted 1981
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
- EC Number:
- 308-114-5
- EC Name:
- Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
- Cas Number:
- 97862-65-2
- Molecular formula:
- C40H28CrN8O10S2.C28H31N2O3.C20H32N
- IUPAC Name:
- Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Code No.: TK10363
- Batch No.: 42.29
- Physical state: Powder
Constituent 1
- Specific details on test material used for the study:
- - Code No.: TK10363
- Batch No.: 42.29
- Physical state: Powder
Test animals
- Species:
- rat
- Strain:
- other: Tif:RAIF (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7 -8 weeks
- Weight at study initiation: 151 - 211 g
- Housing: Animals were caged in groups of 5 in Macrolon cages type 3 with standardised soft wood bedding (Societe Parisienne des sciures, Pantin).
- Diet: Rat food, NAPAG No. 890, NAPAG AG Gossau, Switzerland, provided ad libitum
- Water: Drinking water, provided ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 55 +/- 15
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water containing 0.5 % carboxymethylcellulose and 0.1 % polysorbate 80
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25, 50, 100 mg/mL vehicle
- Amount of vehicle: 10 mL - Doses:
- 250, 500, 1000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- From the body weights the group means and their standard deviations were calculated. Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944).
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 525 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 417 - < 688
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 525 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 345 - < 871
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 525 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 345 - < 871
- Mortality:
- Males
250 mg/kg bw: no mortalities
500 mg/kg bw: 2 mortalities, both 2 h after treatment
1000 mg/kg bw: 5 mortalities, one at 1h after treatment, four at 2 h after treatment.
Females
250 mg/kg bw: no mortalities
500 mg/kg bw: 2 mortalities, both 2 h after treatment
1000 mg/kg bw: 5 mortalities, one at 1h after treatment, four at 2 h after treatment. - Clinical signs:
- other: No specific symptoms were seen, except for transient clonic- tonic muscle spasms in the animals treated with 500 mg/kg.
- Gross pathology:
- No compound related gross organ changes were observed. However, due to the colour of the test item, a red discoloration of the whole body was observed during 9 days in the animals treated with 250 mg/kg and during the whole observation period in the animals treated with 500 mg/kg.
- Other findings:
- The surviving animals recovered within 10 days.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
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